510(k) Report

510(k) · Cleared

Cleared

Connexus

K050690510(k) TraditionalCleared Jul 7, 2005112-day reviewClass II21 CFR 888.3045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Isotis Orthobiologics, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 7, 2005 as substantially equivalent to K040419 (Isotis Orthobiologics, Inc., 2005) and 3 other predicates after a 112-day review. Its family tree reaches back 2 generations to 2004. 6 later devices descend from it.

Decided
Jul 7, 2005
Review
112 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K040980 (2004). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2008: 5 descendants cleared2005: 1 descendant clearedK040980 · Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T · Wrightmedicaltechnologyinc · 2004K040419 · Dynagraft II · Isotis Orthobiologics, Inc. · 2005200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K040419 · Dynagraft II · Isotis Orthobiologics, Inc. · 2005K040980 · Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T · Wrightmedicaltechnologyinc · 20040
  1. Root · 2 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
  2. 1 generation backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
  3. This deviceK050690 ConnexusIsotis Orthobiologics, Inc. · 2005
  4. Descendant · cites it directly · 4 of its ownK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
  5. Descendant · 2 generations on · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
  6. Descendant · 3 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
  7. Descendant · 2 generations on · 0 of its ownK082002 Progenix PlusMedtronic Sofamor Danek · 2008
  8. Descendant · 3 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12008: 5
2005high 5 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008 · cites it directly4descendants
  • K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · 2 generations on2descendants
  • K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · 3 generations on1descendant
  • K082002Progenix PlusMedtronic Sofamor Danek · 2008 · 2 generations on0descendants
  • K082463ProgenixMedtronic Sofamor Danek · 2008 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K040980Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite…Wrightmedicaltechnologyinc2004—
−1K040419Dynagraft IIIsotis Orthobiologics, Inc.2005—
0 (this device)K050690ConnexusIsotis Orthobiologics, Inc.2005—
+1K072265Progenix DMB PuttyMedtronic Sofamor Danek2008—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek2008—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.2008—
+2K082002Progenix PlusMedtronic Sofamor Danek2008—
+3K082463ProgenixMedtronic Sofamor Danek2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200850
FIG. 1 — Lineage of K050690, 2004–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQV device

  1. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K040419Dynagraft II
Cleared while this submission was under review
Summary page 1
…e: Sec. 888.3045 Resorbable calcium salt bone void filler device. 3. Predicate Devices DynaGraft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Le…
Isotis Orthobiologics, Inc.2005—
*K040980Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold…
Summary page 1
…filler device. 3. Predicate Devices DynaGraft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420)…
Wrightmedicaltechnologyinc2004—
*K031399Intergro DBM
Summary page 1
…raft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420) 4. Device Description Connexus is derived from sel…
Interpore Cross Intl.20051
*K043420Osteofil, Optefil, Regenafil, Rti Allograft Paste
Summary page 1
…rt carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420) 4. Device Description Connexus is derived from selected donated human bone tissue that has been processed into part…
Regeneration Technologies, Inc.200513

Also cleared against K040419: 7 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072265Progenix DMB PuttyMedtronic Sofamor Danek20084
K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc.20050

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K072265 (Medtronic Sofamor Danek, 2008) has gone furthest, with 4 descendants of its own.
  • 7 other devices also cite its predicate K040419.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

Connexus is an osteoinductive and osteoconductive bone filling material indicated:

For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.

Indications for use as stated in the FDA summary.

Also cleared against K040419

7 other devices cite the same predicate.

  • K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012
  • K091193Accell EVO3CIsotis Orthobiologics, Inc. · 20091 recall
  • K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
  • K071849Allofuse Gel and PuttyAllosource, Inc. · 20081 recall
  • K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc. · 2007
  • K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007

More from Isotis Orthobiologics, Inc.

10 FDA decisions under this applicant name. See the company

  • K091193Accell EVO3CIsotis Orthobiologics, Inc. · 20091 recall
  • K081817Accell TBM-RIsotis Orthobiologics, Inc. · 2008
  • K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc. · 2007
  • K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
  • K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc. · 2005

Recent decisions in MQV

The MQV category page

  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K050690 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050690: Connexus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050690

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026